AphasiaNCT04048668
tDCS to Treat Subacute Aphasia
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Aphasia and Stroke, Acute, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study proposes to use transcranial direct current stimulation (tDCS), a technique by which a very small electrical current (2 mA) is applied to the scalp, along side speech therapy in patients with subacute stroke and aphasia in order to enhance language recovery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aphasia, Stroke, Acute
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Presence of aphasia attributable to stroke that occurred between 7 days and 3 months (inclusive) prior to inclusion in the study.
- 2. Must be able to understand the nature of the study, and give informed consent.
- 3. English must be their native language where "native" is defined as learning English before the age of 6
Who cannot join
- 1. History of chronic, serious, or unstable neurologic illness(es) other than stroke
- 2. Current unstable medical illness(es)
- 3. History of reoccurring seizures or epilepsy
- 4. Current abuse of alcohol or drugs
- 5. Active or History of major psychiatric disorder
- 6. Pregnancy
- 7. Subjects with metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Institute for Rehabilitation Medicine
Philadelphia, Pennsylvania, 19146
About this study
Official title: Transcranial Direct Current Stimulation to Enhance Language Recovery in Patients With Aphasia After Subacute Stroke
This study proposes to use transcranial direct current stimulation (tDCS), a technique by which a very small electrical current (2 mA) is applied to the scalp, along side speech therapy in patients with subacute stroke and aphasia in order to enhance language recovery. Aphasic patients in an inpatient neurorehabilitation facility who have experienced a stroke between one week and three months prior to enrollment will be invited to participate. Participants will receive either real or sham tDCS to the left hemisphere of the brain for a minimum of 5 consecutive sessions to up-to a max of 10 sessions depending on the length of their rehab stay . Stimulation will be paired with with the patient's normal speech therapy schedule. Participant's language skills will be assessed at baseline and immediately after the last session of therapy in order to determine whether tDCS is associated with either transient or persistent improvement in language.
Read the detailed description
Speech therapy is the standard of care nationwide in treating individuals who have had a stroke and are now experiencing aphasia. Speech therapy can help to rehabilitate language skills and supplement function by teaching alternate strategies for communication; however, these benefits often leave room for further improvement. Researchers have focused their efforts in combining speech therapy with other techniques to boost the effects. In this study, we will combine speech therapy with non-invasive brain stimulation, specifically transcranial direct current stimulation (tDCS), in the hopes of significantly improve language in subacute aphasia patients.
This is a double-blind, randomized, sham-controlled pilot project, where inpatients with subacute stroke and aphasia will be recruited from the Penn Institute for Rehabilitation Medicine hospital (PIRM). The typical patient admitted to PIRM is approximately 1-2 weeks post-stroke. Upon enrollment, baseline aphasia severity will be characterized using standardized measures such as the Western Aphasia Battery (WAB), Pyramids and Palm Trees (PPT) and Philadelphia Naming Test (PNT) by the patient's speech therapist. Subjects will subsequently be randomized to undergo either real or sham tDCS. Subjects will then undergo a minimum of 5-consectuive stimulation session (Monday-Friday) and maximum of 10-consecutive stimulation sessions (Monday-Friday) of either real or sham tDCS. During stimulation, subjects will receive either real tDCS at a current of 2.0 mA for 20 minutes or sham stimulation for an equivalent period of time with a 30sec ramp-up/ramp-down. Sham stimulation mimics real stimulation closely; most subjects cannot distinguish between real and sham tDCS. During stimulation visits subjects will concurrently participate in their regular speech therapy treatment. Speech Therapy will be administered by their speech therapist and will follow whatever protocol the therapist deems useful for standard of care treatment of their aphasia. An immediate follow-up session will also take place, subjects will repeat language batteries including the WAB, PPT and PNT.
- Conditions
- Aphasia, Stroke, Acute
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- non-invasive brain stimulation, tDCS
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Also called Standard of Care Speech Therapy
tDCS is a non-invasive brain stimulation technique by which very small electrical currents (2 mA) are applied to the scalp.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Active comparator | 2mA for 20 minutes Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS | Sham comparator | 30 second ramp-up / ramp-down for 20 minutes Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aphasia Severity
Measured by WAB AQ score. A higher score indicated better language function. Scores can range from 0-100 with any score over 93 considered "recovered".
Measured: Baseline, Immediate Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Sep 2019
- Primary completion15 Jul 2022
- Study completion1 Jul 2024
Why it stopped: Suspended due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048668
- Sponsor's protocol ID
- 813736
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2019
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation to Enhance Language Recovery in Patients With Aphasia After Subacute Stroke
- ClinicalTrials.gov ID
- NCT04048668
- Acronym / sponsor ID
- 813736
- Conditions
- Aphasia, Stroke, Acute
- Keywords
- non-invasive brain stimulation, tDCS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Suspended due to COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to use transcranial direct current stimulation (tDCS), a technique by which a very small electrical current (2 mA) is applied to the scalp, along side speech therapy in patients with subacute stroke and aphasia in order to enhance language recovery. Aphasic patients in an inpatient neurorehabilitation facility who have experienced a stroke between one week and three months prior to enrollment will be invited to participate. Participants will receive either real or sham tDCS to the left hemisphere of the brain for a minimum of 5 consecutive sessions to up-to a max of 10 sessions depending on the length of their rehab stay . Stimulation will be paired with with the patient's normal speech therapy schedule. Participant's language skills will be assessed at baseline and immediately after the last session of therapy in order to determine whether tDCS is associated with either transient or persistent improvement in language.
Detailed description
Speech therapy is the standard of care nationwide in treating individuals who have had a stroke and are now experiencing aphasia. Speech therapy can help to rehabilitate language skills and supplement function by teaching alternate strategies for communication; however, these benefits often leave room for further improvement. Researchers have focused their efforts in combining speech therapy with other techniques to boost the effects. In this study, we will combine speech therapy with non-invasive brain stimulation, specifically transcranial direct current stimulation (tDCS), in the hopes of significantly improve language in subacute aphasia patients.
This is a double-blind, randomized, sham-controlled pilot project, where inpatients with subacute stroke and aphasia will be recruited from the Penn Institute for Rehabilitation Medicine hospital (PIRM). The typical patient admitted to PIRM is approximately 1-2 weeks post-stroke. Upon enrollment, baseline aphasia severity will be characterized using standardized measures such as the Western Aphasia Battery (WAB), Pyramids and Palm Trees (PPT) and Philadelphia Naming Test (PNT) by the patient's speech therapist. Subjects will subsequently be randomized to undergo either real or sham tDCS. Subjects will then undergo a minimum of 5-consectuive stimulation session (Monday-Friday) and maximum of 10-consecutive stimulation sessions (Monday-Friday) of either real or sham tDCS. During stimulation, subjects will receive either real tDCS at a current of 2.0 mA for 20 minutes or sham stimulation for an equivalent period of time with a 30sec ramp-up/ramp-down. Sham stimulation mimics real stimulation closely; most subjects cannot distinguish between real and sham tDCS. During stimulation visits subjects will concurrently participate in their regular speech therapy treatment. Speech Therapy will be administered by their speech therapist and will follow whatever protocol the therapist deems useful for standard of care treatment of their aphasia. An immediate follow-up session will also take place, subjects will repeat language batteries including the WAB, PPT and PNT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS)2mA for 20 minutes |
| Sham tDCS | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS)30 second ramp-up / ramp-down for 20 minutes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Presence of aphasia attributable to stroke that occurred between 7 days and 3 months (inclusive) prior to inclusion in the study.
- 2. Must be able to understand the nature of the study, and give informed consent.
- 3. English must be their native language where "native" is defined as learning English before the age of 6
Key exclusion criteria (7 listed)
- 1. History of chronic, serious, or unstable neurologic illness(es) other than stroke
- 2. Current unstable medical illness(es)
- 3. History of reoccurring seizures or epilepsy
- 4. Current abuse of alcohol or drugs
- 5. Active or History of major psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: Standard of Care Speech TherapytDCS is a non-invasive brain stimulation technique by which very small electrical currents (2 mA) are applied to the scalp. | Device | Anodal tDCS, Sham tDCS |
Primary outcome
Change in Aphasia Severity
Time frame: Baseline, Immediate Follow-up
Measured by WAB AQ score. A higher score indicated better language function. Scores can range from 0-100 with any score over 93 considered "recovered".
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Aphasia and Stroke, Acute, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aphasia Severity (time frame: Baseline, Immediate Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.